MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. CADD-LEGACY® PCA PUMP; PUMP, INFUSION, PCA

Catalog Number 21-6300-02

Device Problems Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311)

Patient Problem Death (1802)

Event Date 07/08/2016

Event Type  Death  

Manufacturer Narrative

A cadd-legacy pca infusion pump was returned for investigation.Visual inspection showed the pump arrived with a remote dose cord.The pump was found intact and in good condition.Functional testing for delivery accuracy was conducted using the returned pump and dose cord, finding the flow delivery within manufacturing specifications.The event history log of the pump showed the device infused as programmed.There was no evidence suggesting the event was caused from an intrinsic defect in the product.

Event Description

User facility reported home care patient was placed on a cadd-legacy pca infusion pump administering a prescribed dose of 0.1mg/hr midazolam on (b)(6) 2016 at 5pm.A nurse observed that the flow rate was set at 1.0mg/hr on (b)(6) 2016 at 5am during a casette change, and that the patient was experiencing difficulties breathing.Patient health aggravated and the family called emergency, who declared the patient passed away at 8am.Additional follow-up reported that customer had no further information related to the event.

Manufacturer Narrative

The reported cadd legacy pca infusion pump was returned for investigation.The returned device was received in good condition, intact without disposable, one remote dose cord was also returned.Visual inspection and functional testing was verified along with the function of the included dose cord.Pump and dose code functioned as designed.The calibration values for the error detection sensors of the pump were verified and found to be within manufacturing specification.The root cause of the issue is customer induced.The event history log showed that the device infused as programed.

Manufacturer Narrative

Additionally, the returned device underwent delivery accuracy testing.Testing found that the pump's delivery accuracy was slightly greater than manufacturing specification; however, it was found to be within system specifications.The device event history log revealed that the device infused as programmed.(b)(4).

• Brand Name: CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5878867
• MDR Text Key: 52204990
• Report Number: 2183502-2016-01733
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/06/2016; 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR